Arena Blog

Lessons Learned from the Medical Device IoT Market

Technology
experts expect the Internet of Things to be dominated by everyday consumer devices such as refrigerators, clothes washers and other appliances; door
locks, thermostats and other home furnishings; watches, eyeglasses and other
wearable items; cars; and robots of all kinds.

However,
health and life sciences is one of the most compelling, yet unheralded,
application areas of IoT technology. In fact, the healthcare industry helped
pioneer IoT.

All the way back in 2008, a company called Proteus
Digital Health won a U.S. patent for a pill you can swallow with a tiny sensor
inside of it. The sensor transmits data about
when a patient takes his or her medication, and pairs with a wearable device to
inform family members if it's not taken at the right time. Anyone else old enough out there to remember
the 1966 film “Fantastic Voyage” where a tiny submarine was in fact the ‘pill’? Sometimes fact is stranger than fiction.

With
the increasing use of sensors by medical devices, remote and continuous
monitoring of a patient’s health is becoming possible. This network of sensors,
actuators and other real time mobile communication devices, referred to as the
Internet of Things for Medical Devices (IoT-MD), is poised to revolutionize the
healthcare industry.

A
connected form of human telematics, healthcare environment promotes the quick
flow of information and enables easy access to it. Improved home care facilities and regular
health updates to clinicians reduce the chances of redundant or inappropriate
care, ensure patient care and safety, and reduce overall costs of care.
Connected health solutions can also be used to track lifestyle diseases such as
hypertension, diabetes and asthma, which also require continuous monitoring.

Peter Lucas, the COO of
Epic Medical Concepts & Innovations (EMCI), a company that translates
scientific research into IoT-ready medical devices, believes the IoT market
introduces particularly exciting possibilities in the life sciences industry.
Within the medical realm, the interconnection of technology is more useful than
the highly touted “big data” at identifying trends, improving response times,
and locating small problems before they become big problems.

“The idea that our
medical devices can communicate with the lab hardware in which they operate in
a meaningful, real-time manner is really exciting,” says Lucas. “It manifests
into improving medical outcomes and finding new breakthroughs, especially for
EMCI in the area of cognitive neuroscience.”

EMCI’s
most recent disruptive medical device technologies include systems that track
physical patient records to reduce errors and speed retrieval time, as well as
report on the status of biological specimens in a hospital setting. “We
envision these IoT systems eventually sitting in hospitals all across the
country and having the ability to communicate with each other” says Lucas.

IoT-MD
will drastically change the face of healthcare monitoring and treatment
outcomes. By providing personalized, optimized and immediate feedback/services,
it will promote a better standard of living and provides a timely and
cost-effective response to help nations around the world improve patient care.
Moreover, recent developments in sensor, internet, cloud, mobility and big data
technologies have led to affordable medical devices and connected health
programs, vastly increasing the potential of IoT-MD to influence further
changes.

But
IoT-MD design challenges are complicated by increasingly stringent regulation
and compliance requirements. After all, human lives
are at stake.

“It's one thing for your
microwave to diagnose itself and call a repair tech; it's another thing
entirely to have medical information passing from device to device,” says
Lucas. “I believe this will be an area that grows quickly, but will result in
missteps along the way. I can almost guarantee there will be breaches of
patient data, unanticipated consequences, etc. But on the other hand,
interconnectivity of this type will also bring about medical innovations that
would otherwise never happen.”

A
modern design solution that
consolidates all compliance information, including a bill of materials (BOM),
the design history file (DHF), and the device master record (DMR), into one
centralized system is imperative to meet regulatory audits. For
medical device companies but a sampling of the popular FDA regulations and
product quality business processes include: 21 CFR Part 11, 21 CFR Part 820 and
CAPA (corrective action and preventive actions). While the list is non-exhaustive, these few
are mentioned most frequently by our clients.

The
IoT-MD industry is defined by a number of high hurdles, such as increasingly
stringent compliance standards, that stand in the way of an OEM’s success. But
for those who can overcome these challenges there is the promise of high
margins…and vast riches.

And true, while compliance challenges are magnified, and risks
are more treacherous in the IoT-MD space, the need to adopt disruptive change
and switch directions quickly while juggling stringent quality concerns impacts
IoT companies of all stripes and translates into higher margins when executed
skillfully with a single all-in-one cloud PLM and QMS solution.

Arena provides a
comprehensive quality management solution to enable medical device IoT
companies answer the rigors of compliance, avoid costly mistakes, and maximize
their competitive advantage. Your entire cross-functional team including supply
chain partners can see quality actions, participate in resolving issues
quickly, and see the quality history.

Our holistic, all-in-one
quality management solution is 100% multi-tenant SaaS, cloud-based with a fast,
best practices implementation so you gain immediate benefits and peace of mind
for regulatory compliance.